Valve Design and Paravalvular Aortic Regurgitation
New Insights from the French Registry
Transcatheter aortic valve replacement (TAVR) has emerged as an important treatment option for patients with severe aortic stenosis who are either inoperable or at high risk for surgical aortic valve replacement. Currently, 2 valves are approved by the Food and Drug Administration for inoperable patients, whereas 9 valves have received the CE (Conformité Européenne) mark in Europe for TAVR.
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In a randomized trial of a balloon-expandable valve, TAVR was found to be noninferior to surgical aortic valve replacement for the primary end point of death but markedly inferior to the standpoint of aortic regurgitation (AR).1 Data from observational studies suggest even higher rates of AR after self-expandable valve implantation.1 Several studies reported increased mortality in patients with AR after TAVR, making it a clinically important end point. In the current issue of Circulation, Van Belle et al5 present an analysis from the French Registry that provides support for the previously published data and offers some new important insights.
Van Belle et al report that, after TAVR, AR ≥ 2+ is 1.65 times (21.5% versus 13%) more frequent after self-expandable (CoreValve; Medtronic, Minneapolis, MN) implantation compared with the balloon-expandable TAVR (SAPIEN or SAPIEN XT; Edwards Lifesciences, Irvine, CA) based on a transthoracic echocardiogram (TTE) performed before discharge. These findings are concordant with most of the previous reports as detailed in our recent meta-analysis and confirmed by several European registries in which both valves are commercially available (Table). As shown in the Table,2–5 there is consistently greater incidence of post-TAVR AR in self-expandable TAVR compared with balloon-expandable TAVR. However, at the CoreValve Extreme Risk Trial presentation at the 2013 Transcatheter Therapeutics meeting, we learned recently that the paravalvular (PV)-AR was much less frequent at 1 year follow-up compared with that seen …